Tests duvakitug in adults with active Crohn's disease over time
Compares duvakitug with placebo in adults with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Baton Rouge, Chapel Hill, Colorado Springs, Columbus, Fayetteville, Gurnee, Kissimmee, Liberty, Lubbock, Mandeville, Maspeth, Mesquite, Metairie, Miami, Monroe, New Albany, New York, Orlando, Philadelphia, Pittsburgh, Providence, San Antonio, Southlake, St Louis, Tampa, Tyler, Vancouver, Westlake, and Wyoming, United StatesSee the 34 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT07184944, who can take part
Where in United States
- GI Alliance - Baton Rouge-Site Number: 8400129Baton Rouge, United StatesTaking people
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074Chapel Hill, United StatesTaking people
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039Colorado Springs, United StatesTaking people
- Medical Associates Research Group-Site Number: 8400063Columbus, United StatesTaking people
- Ohio Gastroenterology Group Inc.-Site Number: 8400006Columbus, United StatesTaking people
- OSU Wexner Medical Center-Site Number: 8400077Columbus, United StatesTaking people
- Cross Creek Medical Clinic-Site Number: 8400057Fayetteville, United StatesTaking people
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049Gurnee, United StatesTaking people
- Clinical Research of Osceola-Site Number: 8400013Kissimmee, United StatesTaking people
- BVL Clinical Research-Site Number: 8400005Liberty, United StatesTaking people
- GI Alliance - Lubbock-Site Number: 8400092Lubbock, United StatesTaking people
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128Mandeville, United StatesTaking people
- MedTraits NY-Site Number: 8400045Maspeth, United StatesTaking people
- SMS Clinical Research-Site Number: 8400035Mesquite, United StatesTaking people
- GI Alliance - Metairie-Site Number: 8400124Metairie, United StatesTaking people
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053Miami, United StatesTaking people
- Columbus Clinical Services LLc-Site Number: 8400038Miami, United StatesTaking people
- Delta Research Partners-Site Number: 8400087Monroe, United StatesTaking people
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100New Albany, United StatesTaking people
- New York Gastroenterology Associates-Site Number: 8400009New York, United StatesTaking people
- NYU Langone Health-Site Number: 8400091New York, United StatesTaking people
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040New York, United StatesTaking people
- Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084Orlando, United StatesTaking people
- University of Pennsylvania School of Medicine-Site Number: 8400072Philadelphia, United StatesTaking people
- The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107Pittsburgh, United StatesTaking people
- University Gastroenterology - GI Alliance-Site Number: 8400103Providence, United StatesTaking people
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054San Antonio, United StatesTaking people
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101Southlake, United StatesTaking people
- Gateway Gastroenterology-Site Number: 8400097St Louis, United StatesTaking people
- NMC Research LLC-Site Number: 8400033Tampa, United StatesTaking people
- Tyler Research Institute, LLC-Site Number: 8400095Tyler, United StatesTaking people
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090Vancouver, United StatesTaking people
- North Shore Gastroenterology Research-Site Number: 8400130Westlake, United StatesTaking people
- Gastroenterology Associates of Western Michigan-Site Number: 8400060Wyoming, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07184944
- Record updated
- 21 October 2026
- Original description
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:Read full original descriptionShow less
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
* 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit
Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
* 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
Inclusion: Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development); Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1; OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study.
Exclusion: Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator; Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.